Pyrazinamide

REMEDYREPACK INC.

FULL PRESCRIBING INFORMATION: CONTENTS*

• PYRAZINAMIDE DESCRIPTION
• CLINICAL PHARMACOLOGY
• INDICATIONS & USAGE
• PYRAZINAMIDE CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• INFORMATION FOR PATIENTS
• LABORATORY TESTS
• DRUG & OR LABORATORY TEST INTERACTIONS
• CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY
• PREGNANCY
• NURSING MOTHERS
• PEDIATRIC USE
• GERIATRIC USE
• PYRAZINAMIDE ADVERSE REACTIONS
• OVERDOSAGE
• DOSAGE & ADMINISTRATION
• HOW SUPPLIED
• STORAGE AND HANDLING
• REFERENCES
• PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

FULL PRESCRIBING INFORMATION

PYRAZINAMIDE DESCRIPTION

CLINICAL PHARMACOLOGY

INDICATIONS & USAGE

PYRAZINAMIDE CONTRAINDICATIONS

• ●     with severe hepatic damage.

• ●     who have shown hypersensitivity to it.

• ●     with acute gout.

WARNINGS

PRECAUTIONS

INFORMATION FOR PATIENTS

LABORATORY TESTS

DRUG & OR LABORATORY TEST INTERACTIONS

CARCINOGENESIS & MUTAGENESIS & IMPAIRMENT OF FERTILITY

PREGNANCY

NURSING MOTHERS

PEDIATRIC USE

GERIATRIC USE

PYRAZINAMIDE ADVERSE REACTIONS

OVERDOSAGE

DOSAGE & ADMINISTRATION

*
**

HOW SUPPLIED

STORAGE AND HANDLING

REFERENCES

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL SECTION

Pyrazinamide Pyrazinamide TABLET Product Information Product Type Human prescription drug label Item Code (Source) NDC:49349-344(NDC:61748-012) Route of Administration ORAL DEA Schedule Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength PYRAZINAMIDE PYRAZINAMIDE 500 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE CROSCARMELLOSE SODIUM DIBASIC CALCIUM PHOSPHATE DIHYDRATE cellulose, microcrystalline Product Characteristics Color Size Imprint Code Shape white 13 mm VP;012 ROUND Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49349-344-02 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA081319 2011-06-30